1. Field of the Invention
With the advent of being able to produce substantially homogeneous compositions of antibodies specific for a particular determinant site, improved approaches to assaying for a wide range of compounds of physiological interest were opened. There are many practical advantages to the use of hybridomas for production of antibodies for use in competitive protein binding assays. By using hybridomas, the antibodies can be produced in a laboratory environment, rather than requiring immunization of animals, which generally results in a heterogeneous gamma-globulin fraction whose properties vary with the number of prior immunogen injections. Furthermore, the antisera obtained from immunization is a heterogeneous mixture of antibody molecules having varying specificities and binding constants.
In many situations, the heterogeneous character of the antisera derived from immunization of mammals can lead to a relatively high percentage of erroneous results. The conventional antisera may include antibodies which recognize conventional components in serum, which may or may not be universally encountered. Thus, situations can arise where false positives are observed due to the binding of components of the antisera to components of the serum sample other than the analyte. Monoclonal antibodies offer an important opportunity to provide antibodies which are specific for one or more determinant sites of an analyte diagnostic for a particular disease state or other physiologic condition of interest.
2. Description of the Prior Art
Lutz, et al., Feline Practice 10, 13-23 (1980) and Lutz et al., "Feline Leukemia Virus", W. D. Hardy et al. (Eds), Elsevier, North-Holland, N.Y. (1980) described an enzyme immunoassay test for group specific antigens for Feline Leukemia Virus infection and for p27 protein in the serum of cats. See also, Lutz et al., Cancer Res. 40: 3642-3651, 1980, and references cited therein. U.S. Pat. Nos. 4,172,124 and 4,196,265 describe the preparation of monoclonal antibodies for tumors.